Role overview

Qualifications

Strong proficiency in SAS and/or R programming.
Hands-on experience creating and validating ADaM datasets.
Expertise in generating Tables, Listings, and Figures (TLFs).
Solid understanding of CDISC standards, including SDTM and ADaM.

Responsibilities

Develop and validate ADaM datasets based on approved specifications.
Implement Statistical Analysis Plans (SAPs) and programming specifications.
Produce high-quality Tables, Listings, and Figures (TLFs) for Clinical Study Reports (CSRs).
Conduct quality control reviews and resolve programming issues.

Key facts

Remote from: Anywhere
Freelance
Consultant
English

Hard skills

Base SAS Clinical Study Design Statistical Analysis Statistical Methods Oncology Immunology Neuroscience Process Improvement Test Automation

Other skills

Analytical Skills
Troubleshooting (Problem Solving)
Problem Solving
Communication
Collaboration
Quality Control

About the company

Diverse Lynx

IT Services & IT Consulting

We are a WBENC and NMSDC certified company helping our clients in their Diversity spending on Staffing or Contingent Workforce Services. Established in 2002 and headquartered out of Princeton-NJ, our 2000+ associates’ strength globally helps clients with talent across Technology, Healthcare, Life Sciences, Aerospace, Automotive, Energy, Pharmaceuticals, Retail, Telecom, Manufacturing and Engineering domains. Our presence in USA, Canada & India helps us support clients in IT, Non-IT, Healthcare, Hospital and Clinical hiring, across the globe.

Company details

Company typeLarge

IndustryIT Services & IT Consulting

Company size1001 - 5000

Links

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Job description

Job Title: Statistical Consultant
Location: Remote
Job Type: Full-Time
Salary: $120,000 – $140,000 per year

Required Technical Skills
Strong proficiency in SAS and/or R programming.
Hands-on experience creating and validating ADaM datasets.
Expertise in generating Tables, Listings, and Figures (TLFs).
Solid understanding of CDISC standards, including SDTM and ADaM.
Experience implementing Statistical Analysis Plans (SAPs).
Knowledge of clinical trial design, statistical methodologies, and regulatory requirements.
Experience supporting therapeutic areas such as Oncology, Immunology, Neuroscience, or other clinical research domains.
Excellent analytical, troubleshooting, and problem-solving skills.
Strong communication and collaboration abilities within cross-functional clinical teams.
Key Responsibilities
Statistical Programming
Develop and validate ADaM datasets based on approved specifications.
Implement Statistical Analysis Plans (SAPs) and programming specifications.
Perform statistical programming using SAS/R while adhering to company standards and SOPs.
Support statistical analyses required for clinical studies and regulatory submissions.
Reporting & Deliverables
Produce high-quality Tables, Listings, and Figures (TLFs) for Clinical Study Reports (CSRs), safety analyses, publications, and regulatory submissions.
Ensure programming outputs are accurate, traceable, and compliant with regulatory expectations.
Perform ad hoc analyses to support study teams and business needs.
Documentation & Quality
Prepare programming specifications, validation documentation, and programming deliverables.
Conduct quality control reviews and resolve programming issues.
Maintain documentation in accordance with internal and regulatory requirements.
Collaboration
Work closely with biostatisticians, clinical operations, data management, and regulatory teams.
Provide programming support throughout the clinical trial lifecycle.
Participate in submission activities, audits, inspections, and regulatory responses.
Process Improvement
Develop reusable macros and automation tools to improve programming efficiency.
Contribute to process improvements and implementation of best practices.
Mentor junior programmers and provide technical guidance when needed.

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.